FDA Approves Aurlumyn for Treatment of Severe Frostbite

The Food and Drug Administration (FDA) has approved Aurlumyn (iloprost), a prostacyclin mimetic, for the treatment of severe frostbite in adults to reduce the risk of finger or toe amputation.

The approval was based on data from an open-label controlled trial that included 47 adults with severe frostbite. Patients were randomly assigned to 1 of 3 groups: iloprost intravenously (IV) for 6 hours daily for up to 8 days (Group 1); iloprost plus an unapproved medication for frostbite (Group 2); or an unapproved medication for frostbite (Group 3). All study participants received IV aspirin and rapid rewarming of the areas with frostbite. To evaluate efficacy, a bone scan was obtained 7 days after initial frostbite to predict the risk of amputation of at least 1 finger or toe.

Findings showed none of the patients in the iloprost monotherapy group (0/16) had a bone scan finding predictive of needing amputation, compared with 19% of Group 2 (3/16) and 60% of Group 3 (9/15). Bone scan abnormality was found to be significantly lower among patients who received iloprost. An assessment of follow-up information showed the need for amputation was consistent with the bone scan findings.

The most common adverse reactions reported with iloprost treatment were headache, flushing, heart palpitations, tachycardia, nausea, vomiting, dizziness, and hypotension. 

“This approval provides patients with the first-ever treatment option for severe frostbite,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. “Having this new option provides physicians with a tool that will help prevent the life-changing amputation of one’s frostbitten fingers or toes.”